Kornimate/medical-research-clean huggingface dataset:
randomized controlled trial of gemcitabine combined with 125i brachytherapy

Conditions: Locally Advanced Pancreatic Cancer

Summary: for patients with unresectable locally advanced pancreatic cancer, the combined use of external-beam radiation therapy (ebrt) and systemic chemotherapy of 5-fu has been widely recognized as the most effective chemoradiotherapy approach.but most patients succumb to local recurrence and metastasis after treatment, and the prognosis remains poor on the basis of the development and superiority of the interstitial brachytherapy and the radiosensitizing effect of gemcitabine, we performed a clinical study to explore the interaction of improved i-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histologically proven * locally advanced pancreatic adenocarcinoma stage * no systemic metastases * age between 18-75 * karnofsky-performance status equal to, or greater than 70 % * at least a 2-dimensionally measurable tumor lesion * adequate renal and liver function * written consent statement * patients' compliance and geographical proximity * life expectancy equal to or greater than 3 months exclusion criteria: * serious psychological disease * pregnancy and inadequate or not secure contraception or breastfeeding women * other previous malignant disease in the past two years * serious systemic concomitant diseases, excluding participation in a trial * other experimental treatment during or within 6 weeks prior to this trial (including chemotherapeutic medicine or immune-therapies) * every other condition or therapy assessed by the physician as an eventual risk for the patient or restricting the aims of the trial * distant metastasis

Keywords: pancreatic cancer locally advanced
jump start plus covid-19 support

Conditions: Mental Health Wellness 1

Summary: the purpose of the study is to further develop and examine the jump start plus covid support (js+cs) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.


Eligibility criteria:
center inclusion criteria: 1. have greater than 30 children ages 2- to 5-years old 2. serve low-income families 3. reflect the ethnic diversity of miami-dade county (60%hispanic, 20% non-hispanic black, 20% non-hispanic white child inclusion criteria: 1. child ages 2-5 years old 2. child enrolled in a childcare center exclusion criteria: * children with feeding tubes or those that bring their own meals.
prevention of pov after paediatric tonsillectomy

Conditions: Vomiting

Summary: tonsillectomy is one of the most frequently performed surgical procedures in children. it remains associated with a high morbidity related to postoperative vomiting (pov), pain, risk of bleeding, and dehydration due to impaired oral intake. current medications for pov have limited efficacy and may even be associated with potential side-effects. non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for pov.

postoperative vomiting (pov) is one of the most common complication in children undergoing tonsillectomy. its incidence is between 62% and 73% when no prophylactic antiemetic is given. because of limited efficacy and side effects with antiemetics, many alternative treatment had been used. acupuncture is simple, inexpensive, and noninvasive with minimal side effects. the objective of this study is to compare two prophylactic antiemetic treatments : * dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia * acupuncture treatment (immediately after induction of anaesthesia and for approximately 20 minutes)

Eligibility criteria:
inclusion criteria: * children aged 2-8 y. * children asa 1-2 * tonsillectomy with or without adenoidectomy exclusion criteria: * american society of anesthesiologists grade greater than or equal to iii (patient with severe systemic disease) * intravenous induction * contraindication to steroids * rash or local infection over an acupuncture point * administration of steroids in the 24 hours before the surgery * use of medication with antiemetic effect within the 24 hours before surgery * gastric or intestinal diseases * refusal of parents

Keywords: tonsillectomy postoperative vomiting (pov) dexamethasone acupuncture
nanocurcumin for prostate cancer patients undergoing radiotherapy (rt)

Conditions: Prostate Cancer

Summary: there is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. the aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * candidate for external beam radiotherapy * ecog performance status 0-2 exclusion criteria: * patients with metastatic prostate cancer * patients with kidney \& liver dysfunction * gastrointestinal disorders such as ibd, reflux and peptic ulcers * any adverse reaction to curcumin

Keywords: curcumin protection, radiation controlled clinical trials, randomized radiation therapy prostate cancer
role of ultrasound-guided lymph node biopsy in axillary staging of breast cancer.

Conditions: Breast Cancer

Summary: the purpose of the study is to estimate the diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer, and also to compare between ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with breast cancer.

axillary lymph node status is an extremely important prognostic factor in the assessment and treatment evaluation of patients with newly diagnosed breast cancer. historically, axillary lymph node dissection (alnd) has been the reference standard for diagnosis and staging. however, this procedure can cause numerous postoperative problems, such as lymphedema , pain, impaired shoulder mobility and arm weakness. furthermore, in this era of mammographic screening, axillary lymph node dissection yields negative results in 80%-85% of patients with t1 cancer. therefore, in recent years, sentinel lymph node biopsy (snb) has replaced axillary dissection for lymph node staging at major medical centers. however, there are some practical issues to be resolved. for example, radiotracer distribution can be slow or faulty, valuable operating room time is expended, and pathologists must make quick decisions based on the analysis of frozen sections or there is the need to undergo two surgical interventions (i.e., removal of primary tumor and snb, and in a next step completion alnd). if nodal positivity could be proven and documented preoperatively, sentinel lymph node biopsy could be bypassed and a decision will be made to perform axillary dissection, which is the standard of care in most node-positive patients.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not. exclusion criteria: * patients who had previously undergone axillary surgery. * patients with metastatic disease and not planned for axillary surgery. * patients with a preoperative diagnosis of a benign lesion or ductal carcinoma in situ. * patients with severe uncorrectable bleeding diathesis. * patients refused to sign consent.

Keywords: axillary lymph node biopsy in breast cancer
improving care through improv: promoting mastery in the moment

Conditions: Caregiver Burden

Summary: the goals of this clinical trial are to: 1) refine the training program, "improving care though improv;" and 2) test the program for its influence self-perceived caregiving mastery (i.e., how persons assess their ability to provide care) among informal caregivers of persons living with moderate dementia. forty-three informal caregivers will be involved in testing the training program. these individuals will be assigned to groups of between 8 to12 caregivers and take part in weekly 2-hour sessions held over a 4-week period. these caregivers will be taught improvisational (improv) theater skills, which involves being in the moment, self-awareness, and responsiveness to others. this group also will be asked to answer surveys questions about themselves and the person receiving care at three timepoints and invited to provide feedback on their training experiences.


Eligibility criteria:
inclusion criteria: * actively engaged in the care of community-dwelling persons living with moderate dementia (4 or 5 on a 7-point dementia-staging scale) who is not likely to be institutionalized within the next 6 months * able to attend at least 3 of the 4 in-person sessions * ability to communicate in english exclusion criteria: potential participants were excluded if they did not meet the above criteria or anticipated moving their person to a skilled nursing facility within the next 6 months.
development of a treatment prognosis calculator for the prevention of suicide

Conditions: Suicidal Ideation

Summary: the goal of this interventional study is to develop and test a treatment prognosis calculator to identify which service members with suicidal ideation or behavior are likely to respond well to the current standard of care treatment and which should instead receive brief cognitive behavioral therapy (bcbt) as a first-line treatment. the main aims of the study are: * aim 1: to develop a novel treatment prognostic calculator to predict response to treatment as usual (tau) and identify treatment-seeking military personnel who are unlikely to respond adequately to tau for the reduction of suicidal ideation. * aim 2: to evaluate the performance of the treatment prognosis calculator in a new sample of treatment-seeking military personnel and determine whether bcbt is more effective than tau for those patients who are predicted not to respond adequately to tau. participants will receive mental health treatment as it is typically administered by their mental healthcare treatment team. members of their mental healthcare treatment team may receive intensive training in bcbt. after their provider has received this training, they may use this treatment as part of standard of care treatment. the timing of this training will be determined randomly. participants will complete self-report assessments at the beginning of the study (baseline) as well as 3, 6, 9 and 12 months after their participant begins. these assessments will include questions about feelings, thoughts, moods, impulses, substance use, and behavior.


Eligibility criteria:
inclusion criteria: 1. female and male active duty service members; 2. =\> 18 years old; 3. engaged in mental health treatment at one of the sites at study enrollment; 4. score \>0 on the columbia suicide severity rating scale (cssrs) screener-recent, or indicated suicidal ideation on questions 4 or 5 of the scale for suicidal ideation, indicating suicidal ideation within the last month; 5. able to understand and speak english; 6. able to provide consent. exclusion criteria: (1) participants with a psychiatric or medical condition that prevents them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication).
online wound electronic medical record (owemr) to decrease amputations in diabetics

Conditions: Wounds; Diabetes Complications; Diabetic Foot; Foot Ulcer

Summary: the purpose of this study is to determine whether using the owemr as part of the standard of care for diabetic foot ulcers reduces the rate of lower limb amputations and to quantify the relationship between glycemic control and the rate of amputation secondary to chronic foot ulcers in type ii diabetes.

the online wound electronic medical record (owemr) is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians. use of the owemr includes digital photography as an objective measurement of wound healing rates.

Eligibility criteria:
* signed informed consent * type i or ii diabetes\* * a break in the skin on the foot ≥ 0.5cm2 * 18 yrs of age or older * hemoglobin a1c value within the last 120 days * no use of investigational agents /devices on study or within 30 days prior to enrollment * subjects who will be locally available for the next 6 months

Keywords: diabetic foot ulcer amputation wounds diabetic foot diabetes complications
post mortem tissue donation of pediatric tumor tissues and cells

Conditions: Pediatric Cancer

Summary: the objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (pdox) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, cbtn, dipg registry, cog).

the objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (pdox) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, cbtn, dipg registry, cog). this model system will then be subjected to 1) comprehensive histopathological and molecular characterizations during serial in vivo sub-transplantations; 2) cryopreserved for long term preservation of tumorigenicity; and 3) used for future biological studies and preclinical drug testing.

Eligibility criteria:
inclusion criteria: * pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology) * signed consent for post mortem tissue donation and autopsy exclusion criteria: * signed consent for post mortem tissue donation and autopsy not obtained
collecting outcomes and managing pain after surgery

Conditions: Surgery

Summary: the primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. the study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.


Eligibility criteria:
inclusion criteria: * aged 18-90 years old who are undergoing elective orthopedic surgery at duke health. * patients must have their own smartphone ios or android device. * patients must be able to read english. exclusion criteria: * lacking capacity to provide consent. * cannot read english * under 18 years of age * older than 90 years of age

Keywords: opioid use pain surgery orthopedic surgery orthopedic
escitalopram for the prevention of pegasys-associated depression in hepatitis c virus-infected patients

Conditions: Depression

Summary: primary end points * incidence of depression defined as a montgomery asberg depression scale score (madrs) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype) * effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with escitalopram (s-citalopram) on frequency and severity of depression in patients with chronic hepatitis c (hcv) treated with peg-interferon alfa-2a (pegasys) and ribavirin, measured by the montgomery asberg depression scale secondary end points * time to depression defined as a madrs score of 13 or higher * incidence of major depression defined by diagnostic and statistical manual iv (dsm-iv) criteria * severe depression according to madrs scale (score 25 or higher) * health related quality of life (hrqol) measured by the short form 36 (sf-36) * sustained virologic response * tolerability * safety * changes/group differences in other psychiatric depression scales (hamilton depression rating scale, beck depression inventory) other investigations: * cognitive function, anxiety (word fluency test, trail making test part a and b, othe scales) * predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, alanine aminotransferase (alat) quotient defined as median alat values before treatment divided by the upper standard value, hcv-rna serum concentration level of fibrosis in liver histology, baseline values of the different psychometric scales) * alanine aminotransferase (alat), aspartate transaminase (asat), thyrotrophin (tsh) * biomarkers (genetic parameters, cytokines,...)


Eligibility criteria:
inclusion criteria: * chronic hepatitis c infection defined as positive anti-hcv antibodies and serum hcv-rna \>1000 iu/ml, naive to antiviral treatment * age \>18 years exclusion criteria: * antidepressive treatment within the last 3 years * psychiatric diseases including major depressive disorders in past medical history * active substance abuse during the last 12 months * pregnancy, lactation, wish to become pregnant * hepatitis b (hbv)/hiv-coinfection * decompensated liver disease, hepatocellular carcinoma, history of bleeding esophageal varices * neutropenia (\<1500/ul), thrombocytopenia (\<70/nl), anemia (\<12g/dl in females, \<13g/dl in males) * history of autoimmune disease * history of organ transplantation, concomitant liver disease, severe cardiopulmonary disease, hemolytic anemia, malignant disease

Keywords: pegasys-induced depression
psoas compartment block (pcb) versus l.a infiltration and remifentanil infusion during evar

Conditions: Analgesic Adverse Reaction

Summary: endovascular aneurysm repair (evar) was introduced in 1990 for the first time as a minimally invasive procedure instead of the conventional open surgical repair, with the aim to decrease morbidity and mortality . nowadays evar has become an acceptable management for patients with infra-renal aortic aneurysms (aaa) . a lot of anesthetic techniques have been used successfully for evar. evar requires sedative analgesic medications to achieve an acceptable level of comfort to the patient and cardiorespiratory stability. this is prospective randomized single blinded study of patients presenting with aorto-iliac aneurysm who will undergo evar. patient's demographic data will be assessed, as well as clinical presentation, intraoperative complications. 30 patients undergoing elective evar will be included and will be divided equally into 2 groups. first group is the psoas compartment block (pcb) (15 patients): 30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical landmark. second group is the la and remifentanil group (lr) (15 patients): lidocaine 5 ml of 2% will be injected subcutaneous as local infiltration then remifentanil infusion with rate 0.03-0.1 μg kg-1 min-1. to achieve visual analog scale (vas) 3 or less. vital date will be recorded as baseline then every 5 minutes till the end of the procedure. vas will be recorded as baseline then every 5 minutes till the end of the procedure. also stress response which will be measured subjectively as vital data and vas and objectively as cortisol level in the blood which will be measured as base line and immediate after the end of the procedure.

anatomical, imaging and clinical studies suggest that psoas compartment block (pcb) which was done at l2-l3 level has a high possibility to include l1-l2 roots, and thus can be suitable for inguinal surgery. in our study, the investigators introduce a modified pcb which will be performed in lateral decubitus by a 120 mm stimulated needle inserted at the junction between the lateral third and the medial two-thirds of a line drawn at l2-l3 interspace, between the interspinous line and a line passing through the posterior superior iliac spine (psis), parallel to the interspinous line . if twitching of the anterior thigh area is observed, the needle is moved slight cranially. when twitching of the inguinal field is observed, bupivacaine 0.5% 30 ml, will be injected

Eligibility criteria:
inclusion criteria: * all elective patients presenting with aortoiliac aneurysm who will undergo percutaneous evar. exclusion criteria: * exclusion criteria included the presence of an aneurysm of the common femoral artery or severe atherosclerotic disease with total occlusion, emergency evar, uncooperative patient, patient on anticoagulation therapy, cerebrovascular disease, poorly controlled hypertension (systolic arterial pressure ≥160 mmhg), poorly controlled diabetes mellitus (random blood glucose ≥200 mg/dl) and renal insufficiency (creatinine \>1.5 mg/dl).

Keywords: evar, analgesia
evaluation of pre-exposure prophylaxis (prep) in pregnant and breastfeeding women

Conditions: HIV-I Infection

Summary: the investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (anc) visit from the gugulethu and one additional facility in the klipfontein-mitchell's plain subdistrict of the metro region (to be identified in conjunction with provincial and local health authorities) midwife obstetric units in cape town (n=600 pregnant women per site). the enrolled women will be followed through 12-months post-delivery.

the objectives of the study are to: 1. determine the distribution of women across the prep cascade: 1. evaluate the proportion of pregnant and breastfeeding women who initiate prep out of all women offered prep 2. evaluate the proportion of pregnant and breastfeeding women who are retained in the prep cohort 3. evaluate the proportion of pregnant and breastfeeding women who initiate prep who adhere to prep using objective dried blood spot measures and subjective measures of self-reported pill count and adherence 4. evaluate the proportion of pregnant and breastfeeding women on prep (and not on prep) who acquire hiv, who transmit hiv to their infant, and who report adverse events 2. evaluate patient and provider-level factors associated with the prep cascade using quantitative and qualitative approaches (including in-depth interviews) 3. apply an established mathematical model to simulate the impact of improvement in the prep cascade on hiv infections averted (maternal and perinatal)

Eligibility criteria:
inclusion criteria: * \>16 years of age, * confirmed hiv-negative (using 2 rapid tests, * confirmed with a 4th generation antigen hiv test; * lives within 20 km. of the clinic; * confirmed to be pregnant; * without psychiatric or medical contraindications to prep exclusion criteria: * concurrent enrollment in another hiv-1 vaccine or prevention trial; * medical hospitalization in the past year for any reason; * receipt of tb treatment in the past 30 days; history of renal disease; * exhibiting psychotic symptoms (including hallucinations, suicidal or homicidal ideation, or violent behavior), * currently or history of taking anti-psychotic medications; * positive hepatitis b surface antigen test on screening; * history of bone fracture not related to trauma; * any other medical, psychiatric, or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study.

Keywords: prevention in pregnant and breastfeeding women hiv pre-exposure prophylaxis (prep)